Spinal Elements, Inc
Carlsbad, CA, US
SPINAL ELEMENTS, INC. appears in FDA device records in Carlsbad, CA. FDA records list 66 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 36 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Spinal Elements, Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Amendia, Inc dba Spinal Elementsenforcement report, recall
- Amendia, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 66FDA records hold 66 510(k) clearances for Spinal Elements, Inc between 2007 and 2026. The busiest year on record is 2016, with 10. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 4 |
| 2008 | 5 |
| 2009 | 5 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 3 |
| 2013 | 3 |
| 2014 | 4 |
| 2015 | 7 |
| 2016 | 10 |
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody System | MAX | Substantially Equivalent | |
| K253559 | Ventana™ A Anterior Lumbar Interbody System | OVD | Substantially Equivalent | |
| K250773 | Luna® Ti Interbody Fusion System | MAX | Substantially Equivalent | |
| K242527 | The Karma® Fixation System | MRW | Substantially Equivalent | |
| K243916 | Primus Spinal Fixation System | NKB | Substantially Equivalent | |
| K234150 | Lucent® XP | MAX | Substantially Equivalent | |
| K231593 | Sapphire X3 Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K231252 | Ventana™ L Spinal System | MAX | Substantially Equivalent | |
| K222833 | Ventana™ C Spinal System | ODP | Substantially Equivalent | |
| K222516 | Mercury® II Spinal System | NKB | Substantially Equivalent | |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | MAX | Substantially Equivalent | |
| K203254 | Lucent 3D Spinal System | MAX | Substantially Equivalent | |
| K202298 | Lucent XP, Lucent XP Curved | MAX | Substantially Equivalent | |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | KWQ | Substantially Equivalent | |
| K190881 | Spinal Elements Navigated Instruments | OLO | Substantially Equivalent | |
| K191576 | Mercury® Spinal System, Overwatch® Spinal System | NKB | Substantially Equivalent | |
| K190289 | Karma® Fixation System | OWI | Substantially Equivalent | |
| K182584 | Lucent® XP | MAX | Substantially Equivalent | |
| K181837 | Spinal Elements Ti-Bond coated devices | MAX | Substantially Equivalent | |
| K180728 | Spinal Elements Cerclage System | OWI | Substantially Equivalent | |
| K172967 | Mercury® Spinal System | NKB | Substantially Equivalent | |
| K170235 | Lucent® | MAX | Substantially Equivalent | |
| K160924 | Amendia Interbody Fusion Devices | MAX | Substantially Equivalent | |
| K161842 | Overwatch Spine System | NKB | Substantially Equivalent | |
| K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System | OVE | Substantially Equivalent | |
| K160465 | Spinal Elements' Spinous Process Plate System | PEK | Substantially Equivalent | |
| K152920 | Savannah-T® Pedicle Screw System | NKB | Substantially Equivalent | |
| K152011 | Lucent Intervertebral Body Fusion Device | MAX | Substantially Equivalent | |
| K153152 | Syzygy Stabilization System | NKB | Substantially Equivalent | |
| K160291 | Optimus ALIF System | OVD | Substantially Equivalent | |
| K152972 | Amendia Stand-Alone Cervical System | OVE | Substantially Equivalent | |
| K151310 | Amendia Interbody Fusion Devices | MAX | Substantially Equivalent | |
| K152460 | Rectangular Corpectomy Cage | MQP | Substantially Equivalent | |
| K152455 | Amendia Cervical Plate System | KWQ | Substantially Equivalent | |
| K151322 | Amendia Interbody Fusion Devices | MAX | Substantially Equivalent | |
| K151705 | Lotus Posterior Cervical/Thoracic Spinal System | NKG | Substantially Equivalent | |
| K150395 | Omega LIF System | MAX | Substantially Equivalent | |
| K151215 | Mercury Spinal System | NKB | Substantially Equivalent | |
| K150061 | Lucent; Lucent Ti-Bond Systems | MAX | Substantially Equivalent | |
| K133218 | Crystal ®; Mosaic ®; Vertu ® | OVE | Substantially Equivalent | |
| K141372 | MERCURY SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K133036 | APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS | MBI | Substantially Equivalent | |
| K132925 | SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK | NKB | Substantially Equivalent | |
| K131427 | LOTUS | KWP | Substantially Equivalent | |
| K122967 | LUCENT | MAX | Substantially Equivalent | |
| K122771 | SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | OVE | Substantially Equivalent | |
| K120467 | SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K120177 | SPINAL ELEMENTS CERCLAGE SYSTEM | JDQ | Substantially Equivalent | |
| K110632 | LUCENT OR LUCENT MAGNUM | MAX | Substantially Equivalent | |
| K113011 | SPARTAN S3 FACET SYSTEM | MRW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004893332 | 3004893332 | SPINAL ELEMENTS, INC. | 3115 Melrose Dr Suite 200, CARLSBAD, CA 92010 US | 2026 | and 19 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- HTWBit, Drill
- OWIBone Fixation Cerclage, Sublaminar
- HTTBurr, Orthopedic
- BSOCatheter, Conduction, Anesthetic
- JDQCerclage, Fixation
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- FSTLight, Surgical, Fiberoptic
- HAWNeurological Stereotaxic Instrument
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- NKGPosterior Cervical Screw System
- HAERongeur, Manual
- MQPSpinal Vertebral Body Replacement Device
- PEKSpinous Process Plate
- ETNStimulator, Nerve
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
Recall records
Showing 25 of 36| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1912-2018 | AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The LIF features a self-locking expansion mechanism that is infinitely adjustable, along with a bullet nose design for minimal impaction and ease of insertion. The LIF is streamlined and available in various implant sizes to fit a variety of patient anatomies and surgical preferences | Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis. | Class II | Open, Classified | |
| Z-0239-2018 | Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture). | Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm. | Class II | Terminated | |
| Z-0325-2018 | Mac Pin Non-Cannulated Screw, 6.5 x 60mm | Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length. | Class II | Terminated | |
| Z-0316-2018 | Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System. | Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length. | Class II | Terminated | |
| Z-1885-2017 | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery | Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol. | Class II | Terminated | |
| Z-0887-2017 | Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region | There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw. | Class II | Terminated | |
| Z-0886-2017 | Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region | There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw. | Class II | Terminated | |
| Z-0883-2017 | Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. | Class II | Terminated | |
| Z-0882-2017 | Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. | Class II | Terminated | |
| Z-0881-2017 | K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone | The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. | Class II | Terminated | |
| Z-0966-2017 | Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1. | Absent tantalum market pin. | Class II | Terminated | |
| Z-0891-2017 | Optimus Fixed Awl | Complaints that the tip of the awl broke after impaction during surgery. | Class II | Terminated | |
| Z-0827-2017 | Zeus-P Lumbar Interbody Device | Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect. | Class II | Terminated | |
| Z-1597-2015 | Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy. | Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device. | Class III | Terminated | |
| Z-0907-2015 | Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device. | Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications. | Class II | Terminated | |
| Z-1266-2013 | Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated | |
| Z-1265-2013 | Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated | |
| Z-1264-2013 | Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated | |
| Z-1263-2013 | Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated | |
| Z-1262-2013 | Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated | |
| Z-1261-2013 | Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated | |
| Z-1260-2013 | Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated | |
| Z-1259-2013 | Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated | |
| Z-1258-2013 | Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated | |
| Z-1257-2013 | Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. | Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. | Class III | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain